Therapy management techniques for an implantable medical device

ABSTRACT

Disclosed is a method and apparatus for automatically adjusting drug infusion rate to optimize treatment therapy. The implantable medical device can communicate with a database or algorithm controlled by a caregiver or physician. Thus, the caregiver may request a therapy change (e.g., infusion rate versus time, pump clock settings, etc.) or a therapy management module may automatically activate the therapy change at some future time for convenience, or for technical or clinical reasons.

This application is a continuation of U.S. patent application Ser. No.10/911,068, filed Aug. 4, 2004, now U.S. Pat. No. 7,072,802, which is acontinuation of U.S. patent application Ser. No. 10/000,712, filed Oct.31, 2001, now U.S. Pat. No. 6,799,149, which claims priority to U.S.Provisional Application Ser. No. 60/259,116, filed Dec. 29, 2000, all ofwhich are incorporated herein by reference in their entirety.

This patent application is related to the following co-pending patentapplications, each of which having the same named inventor and filingdate as the present application:

-   -   a. U.S. patent application Ser. No. 10/001,357, filed Oct. 31,        2001, now U.S. Pat. No. TBD which claimed priority to U.S.        Provisional Application Ser. No. 60/259,008, filed Dec. 29,        2000;    -   b. U.S. patent application Ser. No. 10/000,701, filed Oct. 31,        2001, which claimed priority to U.S. Provisional Application        Ser. No. 60/259,115, filed Dec. 29, 2000; and    -   c. U.S. patent application Ser. No. 10/002,669, filed Oct. 31,        2001, which claimed priority to U.S. Provisional Application        Ser. No. 60/259,022, filed Dec. 29, 2000.

Each of these related co-pending patent applications are incorporatedherein by reference in their entireties.

FIELD OF THE INVENTION

This invention relates to implantable therapy delivery devices such asimplantable drug delivery devices, and more particularly relates toautomated therapy management systems and methods for implantable therapydelivery devices.

BACKGROUND OF THE INVENTION

The medical device industry produces a wide variety of electronic andmechanical devices suitable for use outside and inside the body fortreating patient disease conditions. Devices used outside the body aretermed external while devices used inside the body are termedimplantable and include therapeutic substance infusion devices such asimplantable drug pumps. Clinicians use medical devices alone or incombination with therapeutic substance therapies and surgery to treatpatient medical conditions. For some medical conditions, medical devicesprovide the best, and sometimes the only, therapy to restore anindividual to a more healthful condition and a fuller life. Implantabletherapeutic substance infusion devices can be used to treat conditionssuch as pain, spasticity, cancer, and a wide variety of other medicalconditions.

Implantable medical devices have important advantages over other formsof therapeutic substance administration. For example, oraladministration is often not workable because the systemic dose of thesubstance needed to achieve the therapeutic dose at the target sight maybe too large for the patient to tolerate without very adverse sideeffects. Also, some substances simply will not be absorbed in the gutadequately for a therapeutic dose to reach the target sight. Moreover,substances that are not lipid soluble may not cross the blood-brainbarrier adequately if needed in the brain. In addition, infusion ofsubstances from outside the body requires a transcutaneous catheter,which results in other risks such as infection or catheter dislodgement.Further, implantable medical devices avoid the problem of patientnoncompliance, namely the patient failing to take the prescribed drug ortherapy as instructed.

Implantable medical devices are often used in conjunction with variouscomputer and telecommunication systems and components. Informationobtained by the implantable medical device may be stored andsubsequently transmitted to a physician or patient caregiver or adatabase on demand or automatically. Many ways of using the informationare known including decision making to provide optimum medical care tothe person with the medical condition.

An implantable therapeutic substance infusion device such as animplantable drug delivery device is implanted by a clinician into apatient at a location appropriate for the therapy that interferes aslittle as practicable with normal patient activity. This location istypically a subcutaneous region in the lower abdomen. The proximal ornear end of the infusion catheter is connected to the drug pump infusionoutlet. The catheter is simply a flexible tube with a lumen typicallyrunning the length of the catheter. The distal or far end of thecatheter is positioned to infuse a drug or drug combination to a targetsite in the patient. Target sights in the body included but are notlimited to an internal cavity, any blood vessel, any organ, or othertissue in the body. The drug or other therapeutic substance flows fromthe pump via the lumen in the catheter at a programmed infusion rate totreat the disease condition. The pump typically includes an expansiblereservoir for containing a refillable supply of drug. For example, U.S.Pat. No. 4,692,147 (Duggan) and U.S. Pat. No. 5,445,616 (Kratoska et al)disclose types of implantable pumps that can be used.

Examples of diseases that are treatable include spasticity and chronicintractable pain. To treat spasticity, the distal tip of the catheter istypically surgically positioned in the intrathecal space of thepatient's spinal column. Drug flows out of the distal tip into thecerebral spinal fluid where it baths the spinal cord. By virtue ofmolecular action on nervous tissue in the spinal cord, the patient'sspasticity symptoms are dramatically reduced and the patient becomesmuch more comfortable and competent. Pain patients are treated in muchthe same way.

The infusion rate of the drug pump is typically programmed to bevariable over time. The rate is usually controlled by certain componentsin the pump. The controlled infusion rate is often further set by usingan external device or programmer to transmit into the pump, instructionsfor the controlled infusion. The controlled infusion may be variable astime passes according to the needs of the patient. The instructionsprovided to the pump to control the infusion rate of the drug pump aretypically determined by a medical person. In some cases the patient isable to provide the instructions to the pump via an externalpatient-programming device. In contrast, fixed rate pumps usually cannotbe programmed and are only capable of constant infusion rate.

Once implanted, the implantable medical device will requirere-programming to account for changes in the desired therapy, changes inthe condition being treated, or changes in the placement of the leaddelivering the therapy to the body. This can be accomplished in anynumber of ways including, for example, the patient may manually adjustthe treatment therapy, or the treating physician may manually adjust orre-program the implanted device. In either of these cases, there is nomechanism by which the implanted device may automatically make therapyadjustments or store prior therapy changes for later use and analysis.

It is therefore desirable to provide an implantable therapy deliverysystem that is capable of automatically making therapy adjustments. Itis also desirable to provide an implantable therapy delivery system thatprovides historical information relating to the therapy changes made tothe implanted devices.

BRIEF SUMMARY OF THE INVENTION

In accordance with a preferred embodiment of the present invention, thedrug infusion rate is automatically adjusted by communicating with anoutside-the-pump database or algorithm, the latter controlled by acaregiver or physician or through use of an expert system database.Thus, the caregiver may request a therapy change (e.g., infusion rateversus time, pump clock settings, etc.) for a patient in real time whilea Drug Pump Management Controller System (DPMCS) or a therapy managementmodule may automatically activate the therapy change at some future timefor convenience, or for technical or clinical reasons. Technical reasonsmay include, for example, where routine accessibility to the patient isdifficult. The therapy management module may have direct control toreprogram the pump and/or may provide recommendations to thecaregiver/physician.

Alternatively, the pump may automatically detect (or with the additionof patient message to the pump) that the therapy is not givingacceptable results, and the pump/system would automatically inform thecaregiver/physician of this status.

The pump preferably is coupled to one or more sensors to sensephysiologic or other characteristics of the patient to automaticallyprovide closed-loop feedback control. The automated data acquisition(e.g., therapy parameters, physiologic parameters, etc.) would bepossible by storing any changes to the therapy in a database.

The objects, advantages novel features, and the further scope ofapplicability of the present invention will be set forth in the detaileddescription to follow, taken in conjunction with the accompanyingdrawings, and in part will become apparent to those skilled in the artupon examination of the following, or may be learned by practice of theinvention. The objects and advantages of the invention may be realizedand attained by means of the instrumentalities and combinationsparticularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other advantages and features of the invention will becomeapparent upon reading the following detailed description and referringto the accompanying drawings in which like numbers refer to like partsthroughout and in which:

FIG. 1 is a schematic block diagram of an overall system for therapymanagement of an implantable therapy delivery device in accordance witha preferred embodiment of the present invention.

FIG. 2 is a diagrammatic view of a drug delivery device for use with thepresent invention as implanted within a patient.

FIG. 3 illustrates a typical position in a patient of an implantabledrug delivery device with a catheter implanted at or near a spinal cord.

FIG. 4 illustrates another typical position in a patient of animplantable drug delivery device with a catheter implanted at or near abrain.

FIG. 5 depicts the implantable drug delivery device.

FIG. 6 shows an implantable pump communicating via telemetry with anexternal handheld programming device.

FIG. 7 is a diagrammatic view of an exemplary implantable drug deliverydevice for use with the present invention depicting the various layeredcomponents of the device.

FIG. 8 shows a block diagram of an implantable drug delivery deviceembodiment for use with the present invention.

FIG. 9 is a schematic block diagram of the electronic modules of theimplantable drug pump in accordance with a preferred embodiment of thepresent invention.

FIG. 10 is a schematic block diagram of the therapy management module ofthe implantable drug pump in accordance with a preferred embodiment ofthe present invention.

FIG. 11 is a flow chart depicting the process for determining whethertherapy in the implantable device to be refilled in accordance with apreferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, an implantable therapydelivery device is equipped with automated management controlcapabilities. Although not required, the invention will be described inpart in the general context of computer-executable instructions, such asprogram modules. Generally, program modules include routines, programs,objects, scripts, components, data structures, etc. that performparticular tasks or implement particular abstract data types. Programmodules may be part of a single software program or may be implementedas separate software programs.

FIG. 1 is a schematic block diagram of an overall system for therapymanagement of an implantable therapy delivery device in accordance witha preferred embodiment of the present invention. The overall systemgenerally includes an implantable therapy delivery device 105implantable within a patient, an external device or programmer 110having a therapy management module 115 in accordance with a preferredembodiment of the present invention, a database 120, and a computingnetwork 135 such as the Internet coupled to various entities involved inthe healthcare management of the patient. Such entities may include, forexample, an insurance provider 125, a pharmacy 140, a hospital 145, acaregiver 150, a physician 155, and/or a device manufacture 130. Inalternative embodiments, the therapy management module 115 may beimplemented in other parts of the overall system for therapy managementincluding, for example, in the implantable therapy delivery device 105,or on a server accessible over the computing network 135. Furtherdetails of the therapy management module are discussed in further detailherein. The implantable therapy delivery device 105 may be animplantable drug pump or an implantable pulse generator or both. Theimplantable therapy delivery device 105 is coupled to be inbi-directional communication with the external device 110 via telemetry.The external device 110 may be any computing device capable ofcommunicating with the implantable therapy delivery device 105,including for example, a physician programmer, a patient programmer, ascreening device, a data acquisition device, and the like. Thebidirectional communications may be of any type of telemetry includingRF.

The external device 110 is preferably coupled to the computing network135 for communicating with various healthcare entities essential to themanagement of the treatment therapy of the patient. Also coupled to thenetwork 135 and in communication with the external device 110 is thedatabase 120 storing therapy management information relating to thepatient. The computing network 135 may be, for example, a public networksuch as the Internet, an intranet, an extranet, or a private network.The computing network 135 enables the external device 110 to communicatewith the various healthcare entities and the database 120.

The external device 110 may be coupled to the computing network 135either directly through a modem or may be networked to a personalcomputer that is coupled to the computing network 135 through knowntechniques. The various other entities 125, 130, 140-155 are preferablycoupled to the computing network 135 via a general-purpose computingdevice. The computing devices used by these entities preferably haveinstalled therein a software application that communicates with the drugmanagement module to perform the various scheduling functions to beperformed.

As discussed, implantable drug delivery devices are generally known inthe art. U.S. Pat. No. 4,692,147 (Duggan) and U.S. Pat. No. 5,445,616(Kratoska et al), for example, illustrate the general features of thesedevices. FIG. 2 is a diagrammatic illustration of an exemplaryimplantable drug delivery device 105 for use with the present invention.The system includes the device 105 that may be implanted below the skinof a patient 10 in the abdomen or any other location of the body. Thedevice 105 is typically a pump that delivers drug to a catheter 16/18that is positioned to deliver the drug to specific infusion sites withinthe patient's body (in this case, the spinal cord 12). The distal end ofthe catheter 16/18 terminates in a cylindrical hollow tube having adistal end implanted into a portion of the body by conventional surgicaltechniques. The catheter 16/18 is joined to the implanted device 105 inthe manner shown, and may be secured to the device 105 by, for example,screwing the catheter 16/18 onto a catheter port of the device 105.

The implantable system 105 may include one or more sensors to provideclosed-loop feedback control of the drug delivery system to provideenhanced results. Sensors can be used with a closed loop feedback systemto automatically determine the level of treatment therapy necessary toalleviate the symptoms of the disorder being treated. The sensor isattached to or implanted into a portion of a patient's body suitable fordetecting symptoms of the disorder being treated, such as a motorresponse or motor behavior. The sensor is adapted to sense an attributeof the symptom to be controlled or an important related symptom. Formovement disorders that result in abnormal movement of an arm of thepatient, such as an arm, the sensor may be a motion detector implantedin the arm. For example, the sensor may sense three-dimensional ortwo-dimensional motion (linear rotational or joint motion), such as byan accelerometer. One such sensor suitable for use with the presentinvention is described in U.S. Pat. No. 5,293,879 (Vonk). The sensoralso may be placed in the implantable drug delivery device, for example,to sense drug levels. Those skilled in the art will appreciate that anytype of sensor may be utilized with the present invention. The output ofthe sensor may be coupled by a cable or via telemetry to the input of ananalog to digital converter within the implantable drug delivery device.Alternatively, the output of an external sensor would communicate withthe implantable drug delivery device through a telemetry downlink.

The implantable drug delivery device 105 can be used for a wide varietyof therapies to treat medical conditions (also known as medicalindications) such as pain, spasticity, cancer, and many other medicalconditions. The implantable drug delivery device 105 is typicallyimplanted by a clinician, such as a surgeon, using a sterile surgicalprocedure performed under local, regional, or general anesthesia. Beforeimplanting the therapeutic substance infusion device, a catheter istypically implanted with the distal end position at the desiredtherapeutic substance infusion site and the proximal end tunneled to thelocation where the therapeutic substance infusion device is to beimplanted. The implantable therapeutic substance infusion device isgenerally implanted subcutaneously about 2.5 cm (1.0 inch) beneath theskin where there is sufficient subcutaneous tissue to support theimplanted system. As one example, FIG. 3 illustrates the implantabledrug delivery device 105 coupled to catheter 205, both of which areunder the surface of the skin 4. The catheter 205 is positioned with itsdistal tip in the intrathecal space of the spinal column 3. As anotherexample, FIG. 4 shows the implantable drug delivery device 105 forinfusion of drug into to brain B. The device 105 is coupled to catheter205 with a distal end terminating within the brain B. FIG. 5 illustratesthe various components of the implantable drug delivery device 105 thatare implanted within the patient 10.

Once the therapeutic substance infusion device is subcutaneouslyimplanted into the patient, the incision can be sutured closed and thetherapeutic substance infusion device can begin operation. Theimplantable drug delivery device 105 operates to infuse a therapeuticsubstance at a programmed rate into a patient. The therapeutic substanceis a product or substance intended to have a therapeutic effect such aspharmaceutical compositions, genetic materials, biologics, and othersubstances. Pharmaceutical compositions are chemical formulationsintended to have a therapeutic effect such as intrathecal antispasmodics(e.g., balcofen), pain medications, chemotherapeutic agents, and thelike. Pharmaceutical compositions are often configured to function in animplanted environment with characteristics such as stability at bodytemperature to retain therapeutic qualities, concentration to reduce thefrequency of replenishment, and the like. Genetic materials aresubstances intended to have a direct or indirect genetic therapeuticeffect such as genetic vectors, genetic regulator elements, geneticstructural elements, DNA, and the like. Biologics are substances thatare living matter or derived from living matter intended to have atherapeutic effect such as stem cells, platelets, hormones, biologicallyproduced chemicals, and the like. Other substances are substancesintended to have a therapeutic effect yet are not easily classified suchas saline solution, fluoroscopy agents, and the like. As used herein,the term drug shall refer generally to any therapeutic substance.

The therapeutic substance can be replenished in some embodiments of theimplanted therapeutic substance infusion device by inserting anon-coring needle connected to a syringe filled with therapeuticsubstance through the patient's skin into a septum and into a reservoirin the therapeutic substance infusion device to fill the implanteddevice reservoir. Refill kits are available which include the drug andall other necessary equipment needed for the medical attendant to refillthe pump.

A therapeutic substance bolus can be administered by a clinician, insome embodiments, by inserting a non-coring needle connected to asyringe into a catheter access port. This procedure can be used forseveral other reasons including reopening the catheter if it becomesoccluded or to withdraw a sample of cerebral spinal fluid forinvestigative purposes.

FIG. 6 illustrates a typical pump programming technique. An externaldevice, a handheld programming device 110 in this embodiment, transmitsand receives radio frequency signals 212 to and from the implantabledrug delivery device 105. The radio frequency signals 212 sent to thepump, often called the downlink signal, contain the programminginstructions needed by the implantable drug delivery device 105 for itto correctly infuse a drug into the patient from its drug reservoir.Many other types of information may be sent to the pump includingrequests for information residing in the pump in accordance with thepresent invention (discussed herein).

The implantable drug delivery device 105 may continuously orperiodically store various types of information including, for examplewithout limitation, pump diagnostics, drug delivery information, batterlife, etc. Further, the implantable drug delivery device 105 may receiveinformation from various sensors inside the pump or information fromsensors integral with the catheter, thereby obtaining physiologicalinformation about the patient. Even further, the implantable drugdelivery device 105 may store historical data about the drug infusingprofile, patient requests for more drug or other such information.

Such information stored in the pump may be valuable to the treatingphysician and/or the medical device supplier and can be retrieved fromthe pump. In particular, the information stored in the implantable drugdelivery device 105 may be retrieved in response to a request by thepump from the programming device 110. After the request is received andprocessed in the implantable drug delivery device 105, the implantabledrug delivery device 105 prepares the requested information and sends itto the programming device 110, sometimes called uplink data. The pumpinformation received by the programming device 110 is processed andconverted to intelligible data for clinical or technical use. Thisintelligible data can be used for many purposes including management ofthe pump performance, management of the patient therapy, and/or othermedical or record-keeping purposes.

Referring back to the embodiment of the implantable drug deliverydevice, the present invention may be implemented for use any number ofsuch devices. FIG. 7 show one such example of the implantable drugdelivery device 105 and FIG. 8 shows a block diagram of the implantabledrug delivery device 105. The implantable drug delivery device 105generally comprises a housing 1141, a power source 1242, a therapeuticsubstance reservoir 1244, a therapeutic substance pump 1246, andelectronics 1248. The housing 1141 is manufactured from a material thatis biocompatible and hermetically sealed such as titanium, tantalum,stainless steel, plastic, ceramic, and the like. The power source 1242is carried in the housing 1141. The power source 1242 is selected tooperate the therapeutic substance pump 1246 and electronics 1248 such asa lithium ion (Li+) battery, capacitor, and the like.

The therapeutic substance reservoir 1244 is carried in the housing 1141.The therapeutic substance reservoir 1244 is configured for containing atherapeutic substance. The therapeutic substance reservoir 1244 may berefilled with therapeutic substance while implanted via port 1140. Thetherapeutic substance pump 1246 is carried in the housing 1141. Thetherapeutic substance pump 1246 is fluidly coupled to the therapeuticsubstance reservoir 1244 and electrically coupled to the power source1242. The therapeutic substance pump 1246 is a pump that is sufficientfor infusing therapeutic substance such as a piston pump, a peristalticpump that can be found in the SynchroMed® Infusion System available fromMedtronic, Inc., or a pump powered by a stepper motor, an AC motor, a DCmotor, an electrostatic diaphragm, a piezoelectric diaphragm, apiezoelectric motor, a solenoid, a shape memory alloy, and the like.

The electronics 1248 are carried in the housing 1141 and coupled to thetherapeutic substance pump 1246 and the power source 1242. Theelectronics 1248 include a processor 1405, memory 1410, an infusionprogram in memory, and transceiver circuitry 1415. The processor 1405can be an Application Specific Integrated Circuit (ASIC) state machine,a gate array, controller, and the like. The electronics 1248 areconfigured to control the infusion rate of the therapeutic substancepump 1246 and can be configured to operate many other features such aspatient alarms 1420 and the like. The infusion program resides in memoryand is capable of being modified once the implantable drug deliverdevice is implanted. The transceiver circuitry 1415 is coupled to theprocessor 1405 for externally receiving and transmitting therapeuticsubstance infusion device information.

As discussed, the present invention is implemented in part the generalcontext of computer-executable instructions, such as program modules. Ina preferred embodiment as discussed herein, some of the features of thepresent invention are implemented within a therapy management module115. The implantable device 105 would provide via telemetry thenecessary information for the external device 110 to provide the therapymanagement functionality of the present invention. In the embodimentwhere the therapy management module 115 is within the implantable device105, it may be found in the electronics 1248.

Referring to the schematic block diagram of FIG. 9, the implantabledevice 105 includes various electrical and software components includinga microprocessor 730, a flow control module 740 for controlling the flowof drug from the reservoir to the infusion port, a telemetry module 720for providing bidirectional communication between the implantable device105 and the external device 110, a memory 725 for storing the varioussoftware modules for use with the present invention, a therapy monitormodule 735, and (optionally) a therapy management module 115. Thetherapy monitor module 735 provides one or more performance parametersrelated to therapy management including, but not limited to, drug flowrate, drug quantity in reservoir, drug type, drug usage history, etc.Drug usage monitored by the therapy monitor module 735 may include, forexample and without limitation, the quantity drug consumed by thepatient, the rate in which the drug is being consumed by the patient,and the estimated date that the drug in the pump will be exhausted basedon the previous two parameters. Drug usage may be determined, forexample, by way of a pump reservoir sensor 750 that senses the amount ofdrug remaining in the pump reservoir. For example, the pump reservoirsensor 750 disclosed in U.S. Pat. No. 6,099,495, having application Ser.No. 09/070,255, filed Apr. 30, 1998, and entitled “Reservoir VolumeSensor”, may be used.

The external device 110 generally includes a telemetry module 705 and amemory 710 for storing various software applications and modules for usewith the present invention. Stored within the external device 110 is thetherapy management module 115. The therapy management module 115 gathersdata regarding the implantable device 105 to make decisions regardingthe management of medical therapy. Such decisions include, but are notlimited to, reprogramming of the implanted device 105, warningsassociated with the therapy to the patient/caregiver/physician, changeddrug formulations, etc. The patient/caregiver/physician areautomatically notified of any such changes. Provisions in the systemallows for confirming or other responses to insure adequatecommunication and commitment for action. All data and fiducial markers(e.g., date, requester) are sent to database 120 for archive andpotential later retrieval.

Database 120 includes a human clinical records database of therapyperformance related to various indications and various drug used totreat those indications. This database 120 is likely generated fromvarious sources, including previous pump patient experience, and isconstantly updated and managed. This database is preferably accessibleby the therapy management module 115.

The pump telemetry data is obtained by or through the external device110 that is held in reasonable proximity with the pump 105 implantedwithin patient. The external device 110 interrogates the implanted pump105 and information is uplinked from the pump 105 to the external device110. In addition, data from the pump is provided to the therapymanagement algorithm 830 (discussed herein).

As shown in the block diagram of FIG. 10, the data regarding theimplantable device 105 that the therapy management module 115 uses tomake its determination include, for example, pump performanceinformation from the therapy monitor module 735, pump manufacturerrequirements 820, physician requirements 815, and patient requirements825. The pump manufacturer requirements 820 preferably provides acontinuous real time input to the therapy management module 115 to allowthe pump manufacturer to specify limits for changing therapy parametersto conform with the design of the implanted device 105. The physicianand patient requirements 815 and 825 include requirements of the drugtherapy that are selectable and generally specific to the patient and/orphysician therapy preferences (e.g., flow rate). These requirements 815and 825 are determined by the physician who may input these requirementsvia a general-purpose computing device. The therapy management algorithm830 receives the requirement information 815-825 either by manual entryof the information or could be downloaded via the Internet, a localnetwork, or a telephone line. For archival purposes, all data is storedin database 120.

Still referring to FIG. 10, the therapy management module 115 includes atherapy management algorithm 830 that serves to determine the managementof the medical therapy provided to the patient.

FIG. 11 is a flow chart illustrating the procedure followed by thetherapy management module 115. As discussed above, the therapymanagement module 115 utilizes a therapy management algorithm 830 tomake this determination. At step 905, the therapy management algorithm830 determines whether a therapy change is needed. The therapymanagement module 115 may make this determination either continuously,periodically (e.g., on a daily basis), or even manually (e.g., manuallyinterrogating the implantable device 105 for it's drug status and druginfusion rate conditions). If a therapy change is not required, a recordthat this determination was made is stored in the database 120 (at step920). On the other hand, if the therapy management algorithm 830determines that a therapy change is required, at step 910, the therapymanagement module 825 performs a reprogramming of the pump 105. At step920, event data (such as the therapy change) are stored in the database120. Finally, at step 925, whether or not the therapy is changed, thetherapy management algorithm 830 requests payment for the therapymanagement service.

For example, in one embodiment, the sensor data from sensor 750 could bebody vibration or activity information when the body vibration is due totremor in an extremity. The therapy management algorithm 830 comparesthis sensor output or level of tremor to the physician requirements 815which may be a low level of tremor and if the tremor level is too great,either in frequency or amplitude or some combination, the therapymanagement algorithm 830 could decide that a therapy change is needed.This information is transmitted to database 120 and the pump 105 isreprogrammed to infuse a larger amount of the antitremor agent.Alternatively, if the tremor level is not so great so as to require atherapy change, then this information is communicated to the database120 and the pump 105 is not reprogrammed to infuse additional drug.Thus, in this example, a main decision the therapy management algorithm830 makes is to compare the physician requirements 815 for the level oftremor to what they pump 105 actually senses is the tremor level. Adecision is then made by the therapy management algorithm 830 as towhether to reprogram the pump for additional drug infusion.

When the event is added to the database 120, the therapy managementalgorithm 830 decides whether a payment request for this therapymanagement procedure should be made or whether payment request should bemade, depending on whether the pump 105 is reprogrammed.

In another embodiment, the physician requirements 815 could be replacedwith clinical data guidelines information. The therapy managementalgorithm 830 and all other elements of the flow chart would be the samewith the exception that the therapy management algorithm 830 would usethe clinical data guidelines to determine whether or not the pump shouldbe reprogrammed. Alternatively, the physician requirements 815 could beused in a secondary level with the clinical data guidelines as a primaryreference for the therapy management algorithm 830.

When the therapy management algorithm 830 makes a decision for pumpprogramming, it is accomplished using the external device 110 beingplaced in reasonable proximity to the pump 105 in the patient.

It will be appreciated that the present invention may be implementedusing other embodiments. Those skilled in the art recognize that thepreferred embodiments may be altered and modified without departing fromthe true spirit and scope of the invention as defined in the appendedclaims.

1. An implantable drug delivery system having a data delivery feature,comprising: an external device; a housing; a drug reservoir positionedin the housing and configured to contain a therapeutic substance; aninfusion port in fluid communication with the drug reservoir; a pumpconfigured to direct the therapeutic substance from the drug reservoirto the infusion port; and electronics coupled to pump and configured tocontrol the flow of therapeutic substances from the drug reservoir tothe infusion port, the electronics including a memory configured tostore performance information and programming, the electronics furtherconfigured to monitor the flow of the therapeutic substance, wherein theelectronics is configured to be in bi-directional communication with theexternal device and to provide performance information from the memoryto the external device and to receive changes to the programming in thememory from the external device.
 2. The implantable drug delivery systemof claim 1, further comprising a sensor configured to provide feedbackto the electronics.
 3. The implantable drug delivery system of claim 1,wherein the external device is configured to be coupled via a network toat least one entity selected from a group consisting of an insuranceprovider, a pharmacy, a hospital, a caregiver, a physician and a devicemanufacture.
 4. The implantable drug delivery system of claim 1, whereinthe external device comprises a data-acquisition device.
 5. Theimplantable drug delivery system of claim 1, further comprising acatheter with a distal end extending from the housing, wherein catheteris fluidly coupled to the drug reservoir and the distal end is coupledto the infusion port.
 6. The implantable drug delivery system of claim1, wherein the pump is positioned in the housing.
 7. The implantabledrug delivery system of claim 1, further comprising a pump reservoirsensor.
 8. The implantable drug delivery system of claim 1, wherein theexternal device is in communication with a database, the databaseincluding algorithms for modifying the programming of the electronicsbased on performance data provided to the external device.
 9. Theimplantable drug delivery system of claim 2, wherein the electronics isconfigured to modify the flow of the therapeutic substance in responseto the feedback and the programming in the memory.
 10. The implantabledrug system of claim 3, wherein the network includes a connection overan Internet.
 11. The implantable drug delivery system of claim 3,wherein the network includes a connection over a land-based line.
 12. Animplantable drug delivery device, comprising: a housing; a drugreservoir positioned in the housing and configured to contain atherapeutic substance; an infusion port in fluid communication with thedrug reservoir; a pump in the housing, the pump configured to direct thetherapeutic substance from the drug reservoir to the infusion port;electronics coupled to the pump and configured to control the flow oftherapeutic substances from the drug reservoir to the infusion port, theelectronics including a memory configured to store performanceinformation and programming, the electronics further configured tomonitor the flow of the therapeutic substance and to communicate with anexternal programmer via a network so that performance information of theimplanted drug delivery device can be reported and programming on thedevice can be modified based on the performance information; and asensor configured to in provide feedback to the electronics; wherein theelectronics is configured to accept programming via telemetry so as tocontrol whether the therapeutic substance is delivered through theinfusion port based on the feedback received from the sensor.
 13. Theimplantable drug delivery system of claim 12, wherein the network is anInternet.
 14. The implantable drug delivery system of claim 12, whereinthe network includes a connection over a land-based line.
 15. Theimplantable drug delivery system of claim 12, wherein externalprogrammer comprises a database.
 16. The implantable drug deliverysystem of claim 15, further comprising a pump reservoir sensor.
 17. Animplantable drug delivery device, comprising: a housing; a drugreservoir positioned in the housing and configured to contain atherapeutic substance; an infusion port in fluid communication with thedrug reservoir; a pump configured to direct the therapeutic substancefrom the drug reservoir to the infusion port; a microprocessorpositioned in the housing and configured to control the pump, themicroprocessor including a memory configured to store performanceinformation and programming, the microprocessor further configured tomonitor the flow of the therapeutic substance and to use bi-directionalcommunication with an external programmer so that performanceinformation of the implanted drug delivery device can be reported andprogramming on the device can be modified based on the performanceinformation.
 18. The implantable drug delivery system of claim 17,wherein the microprocessor is configured to communication with theexternal programmer via an Internet connection.
 19. The implantable drugdelivery system of claim 17, further comprising a sensor configured tosense characteristics of a patient, wherein the microprocessor isconfigured to receive signals received from the sensor and store them inthe memory.
 20. The implantable drug delivery system of claim 19,wherein the microprocessor is configured to determine whether a therapychange is needed based on the signals received from the sensor.